Full-Time
Salary: 25k to 30k
Positions: 10

Pharmacovigilance Services Associate

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Job Description

 Location: Remote – India
Job ID: R0000036088
Category: Clinical Trials
Employment Type: Full-time
Company: Parexel

About the Role

As a CTIS Administrator at Parexel, you will play a critical role in ensuring the successful planning, coordination, and delivery of European Union Clinical Trials Directive/Regulation (EUCTD/R) reporting requirements through the European Medicines Agency (EMA) Clinical Trial Information System (CTIS).

You will collaborate closely with Regulatory Affairs, Clinical Trial Management, and Clinical Transparency teams to manage clinical trial applications (CTAs) and ensure timely and compliant reporting throughout the clinical study lifecycle. This role is ideal for professionals who thrive in a fast-paced, global regulatory environment and are passionate about driving operational excellence in clinical research.

Role & Responsibilities

  • Collaborate with Regulatory Affairs to plan and manage Clinical Trial Applications (CTAs) across EU countries.
  • Coordinate with Clinical Trial Management to align on study milestones, timelines, and country allocations.
  • Work with Clinical Transparency teams to manage redactions and document preparation for submissions.

  • Identify and document participating Member States, Institutions, and Principal Investigators (PIs) within the CTIS database.
  • Capture and maintain all study-level and country-level milestones (e.g., Study Start, Completion, Enrollment timelines, and holds/restarts).

Educational Qualification

Education:

  • Bachelor’s degree in Life Sciences, Regulatory Affairs, or a related discipline.

Experience:

  • Minimum 1–3 years of relevant experience in clinical trial documentation, regulatory submissions, or clinical operations.
  • Experience with clinical essential document review or working in CTMS/eTMF environments preferred.

Location

 Remote – India

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